Numbers from Biogen

[Scooter24]

For those of you that like numbers I was on a teleconference with Biogen today they said the total # of people world wide on Ty was 92,200. Thier number for worst case chance of getting PML is 11 in a 1000 if you meet the highest risk factor of over 24 infusions, JCV + and prior use of imuno supressents. W/o those 3 it is less than 1 in a 1000.

[Lendi]

Thanks for the info. When talking to my neuro yesterday he said the chances can be as bad as 1 in 100 or good as 1 in 1,000,000. That was so not helpful.

[LL60]

How do you go from 11:1000 to 1:100??

[Scooter24]

Those two numbers are pretty much the same if you think about it, it would be the same as 5 in 500 or 110 in 10,000. guess it is one of those lass 1/2 full or 1/2 empty. My nuero told me something and it made sense, If there are a 1000 people in a room holding raffle tickets for $100 prize and they pull 11 tickets for it, what are my chances of winning?

[LL60]

Thanks Scooter24 - my math leaves much to be desired.

[0485c10]

Timely Post

My web crawler picked up a post on a pharmaceutical sales message board. I'm not a pharma rep so i was not able to reply or even read the entire post. Just the first sentence.

Keeping Score: Tysabri 42, Gilenya 11 BiogenIdec.

It sounds like Biogen(Tysabri) was claiming victory.
I understand why too.

If you scale the 11 up to tysabri current use:
30,000(gilenya)-> 90,000(tysabri) & 1 year post marketing(gilenya)-> 5 years post marketing(tysabri)after review and re-release.

it would be: Tysabri 42 Gilenya 165

alternatively you can scale down Tysabri's 42 to gilenya current use: 90,000->30,000 & 1/5 amount of time

it would be:Tysabri 3 Gilenya 11.

All in all i think we made good decision to stay on tysabri after gilenya was released.

i have a bad feeling about gilenya, that i don't have about BG12 yet. we'll see how it plays out..

[0485c10]

Scaling for jcv+..too.

Actually you can scale it even farther...

the label the fda has agreed with tysabri's #'s that 50% are JCV+ and 50% are not. and all who have gotten PML were jcv+

so by that..45,000 users of tysabri are jcv+.



Scale Gilenya up to Tysabri jcv+ levels(30,000 *1.5 = 45,000) & 5 years post marketing:

would be: Tysabri(jcv+) 42 Gilenya 82

or scale tysabri down to gilenya's current usage levels and time

would be: Tysabri (jcv+)5.6 Gilenya 11...

Gilenya would not have been a good choice even if jcv+

[LL60]

I read all the stuff the FDA just posted on the JCV test. It seems like they are adding that to what you have to do to be on Tysabri. Is that how you are reading it? Will you have to take the test? To be accurate, does it have to be done by Quest labs? My doctor already told me the one our hospital does isn't real accurate. (then why do it!!!)

Has anyone who hasn't had the test been told they now have to get it.

I don't have an app. until spring, but I just want to be prepared. I have been refusing it for the last two visits now.

I know my group is backing off of gilenya because a patient got chicken pox while on it and died. So maybe Tysabri is looking better and better to them.

Thanks for all the work you put into the numbers 0485c10. But I have been looking at numbers for almost 3 years now, and when it comes down to it, how I am doing counts the most. And I am doing great on this drug. Great. Amazingly great. Pin cushion feeling all all.

[0485c10]

How I'm reading it is... the FDA is being very careful to not make the jcv test a requirement..after the review and return to market..the FDA is keeping more of a hands off approach to using tysabri and let the doc's make the decision given the information.

my doc has said she will not order a jcv test until it is approved by the fda. its approved now, i'm uncertain if the blood has to be sent out to Quest lab?

i know that she has said that even with jcv + status the risk is very low(when i asked about the test a few years ago)

I'm on medicare which covers tysabri better than an oral or self injectable med. So I'm curious to know my status but financially it would be be a bad time to switch to something else this year. Better in 2 years and best in 3 years.

i'm on 6 week infusions and doing well with that. i may ask to go to 8 week infusions. mostly becaus i like not having monthly infusion better than having monthly infusions.

my next appointment in spring i will bring up the topic of the test, let her know i am curious about it, but it will not affect my decision for 2 more years optimally...then i am interested in switching to BG-12. It will have been on the market for a year by that time.

i think the biggest risk of requiring the jcv test will be private insurance and i am speculating that they will require the test before approval to start tysabri, those already using tysabri will be grandfathered in. just speculation how it will play out.

i was surprised when i was unexpectedly diagnosed with MS after being told i might have ms after being treated for optic neuritis in 1985. it cleared up i thought that meant there was no risk of MS.

then when diagnosed i worried about all the years i had ms without knowing it & the things i thought were just me and more likely it was ms.

i worried about what it had done to me and my doc said when i told her of my worry..."I don't treat the past, I don't treat the future, I treat the present."

currently the jcv test is not required. Period. End of subject. You will be surprised if it does become a requirement. You would prefer not to know. It will not affect your decision. Period. End of subject. IMO

[0485c10]

Oh and i want to switch off tysabri whether jcv+ or -, i just don't like having to go for monthly infusions...so the test doesn't matter to me either--for opposite reasons.

[Scooter24]

0485- Someone else asked about spreading the infusions to 6 or 8 weeks during the call also, they said they are hearing about it from patients and they are talking to dr's to see if anything can be learned from it but they are "not officially" testing or recording the input they rcv, when asked what they felt is the proper dosage those there said that Biogen does not have a "perfect" dosage time frame and that needs to be discussed with your dr, somewhat non- commital.

[0485c10]

Interesting scotter thanks for posting that also. my doc says i respond to meds very well, so if a lesser dose is needed for some, i would be someone who would need less.

cheap drunk too.

[golfore]

Every 8 weeks

Because, I only had 4 or 5 flares in my 23 years, I started on an every 8 week schedule last May. I had a flare last month and have gone back on an every 4 week schedule.